Exclusion Device and System For Delivery

ABSTRACT

A medical flow restrictor that may be used to exclude a saccular aneurysm from the circulatory system. The device, a thin walled, foil-like shell, is compacted for delivery. The invention includes the device, electroforming fabrication methods, delivery assemblies, and methods of placing, and using, the device. A device with an aneurysm lobe and an artery lobe self-aligns its waist at the neck of an aneurysm as the device shell is pressure expanded. Negative pressure is used to collapse both the aneurysm lobe and the artery lobe, captivating the neck of the aneurysm and securing the device. The device works for aneurysms at bifurcations and aneurysms near side-branch arteries. The device, unlike endovascular coiling, excludes the weak neck of the aneurysm from circulation, while leaving the aneurysm relatively empty. Unlike stent-based exclusion, the device does not block perforator arteries. This exclusion device can also limit flow through body lumens or orifices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. §119(e)to provisional application No. 60/799,758, filed May 12, 2006, and toprovisional application No. 60/855,872, filed Nov. 1, 2006, each ofwhich are incorporated herein by this reference.

TECHNICAL FIELD

The present invention relates to the field of medical intraluminaldelivery of an implantable device that reduces or stops fluid movementthat would otherwise flow or circulate through a body lumen or orifice.The invention is well suited for the treatment of neurovascularaneurysms or any other condition that could benefit by completely, orpartially, excluding flow through a body orifice or vessel.

BACKGROUND OF THE INVENTION

An aneurysm forms when a dilated portion of an artery is stretched thinfrom the pressure of the blood. The weakened part of the artery forms abulge, or a ballooning area, that risks leak or rupture. When aneurovascular aneurysm ruptures, it causes bleeding into the compartmentsurrounding the brain, the subarachnoid space, causing a subarachnoidhemorrhage. Subarachnoid hemorrhage from a ruptured neurovascularaneurysm can lead to a hemorrhagic stroke, brain damage, and death.Approximately 25 percent of all patients with a neurovascular aneurysmsuffer a subarachnoid hemorrhage.

Neurovascular aneurysms occur in two to five percent of the populationand more commonly in women than men. It is estimated that as many as 18million people currently living in the United States will develop aneurovascular aneurysm during their lifetime. Annually, the incidence ofsubarachnoid hemorrhage in the United States exceeds 30,000 people. Tento fifteen percent of these patients die before reaching the hospitaland over 50 percent die within the first thirty days after rupture. Ofthose who survive, about half suffer some permanent neurologicaldeficit.

Smoking, hypertension, traumatic head injury, alcohol abuse, use ofhormonal contraception, family history of brain aneurysms, and otherinherited disorders such as Ehler's syndrome, polycystic kidney disease,and Marfan syndrome possibly contribute to neurovascular aneurysms.

Most unruptured aneurysms are asymptomatic. Some people with unrupturedaneurysms experience some or all of the following symptoms: peripheralvision deficits, thinking or processing problems, speech complications,perceptual problems, sudden changes in behavior, loss of balance andcoordination, decreased concentration, short-term memory difficulty, andfatigue. Symptoms of a ruptured neurovascular aneurysm include nauseaand vomiting, stiff neck or neck pain, blurred or double vision, painabove and behind the eye, dilated pupils, sensitivity to light, and lossof sensation. Sometimes patients describing “the worst headache of mylife” are experiencing one of the symptoms of a ruptured neurovascularaneurysm.

Most aneurysms remain undetected until a rupture occurs. Aneurysms,however, may be discovered during routine medical exams or diagnosticprocedures for other health problems. Diagnosis of a ruptured cerebralaneurysm is commonly made by finding signs of subarachnoid hemorrhage ona CT scan (Computerized Tomography). If the CT scan is negative but aruptured aneurysm is still suspected, a lumbar puncture is performed todetect blood in the cerebrospinal fluid (CSF) that surrounds the brainand spinal cord.

To determine the exact location, size, and shape of an aneurysm,neuroradiologists use either cerebral angiography or tomographicangiography. Cerebral angiography, the traditional method, involvesintroducing a catheter into an artery (usually in the leg) and steeringit through the blood vessels of the body to the artery involved by theaneurysm. A special dye, called a contrast agent, is injected into thepatient's artery and its distribution is shown on X-ray projections.This method may not detect some aneurysms due to overlapping structuresor spasm.

Computed Tomographic Angiography (CTA) is an alternative to thetraditional method and can be performed without the need for arterialcatheterization. This test combines a regular CT scan with a contrastdye injected into a vein. Once the dye is injected into a vein, ittravels to the brain arteries, and images are created using a CT scan.These images show exactly how blood flows into the brain arteries. Newdiagnostic modalities promise to supplement both classical andconventional diagnostic studies with less-invasive imaging and possiblyprovide more accurate 3-dimensional anatomic information relative toaneurismal pathology. Better imaging, combined with the development ofimproved minimally invasive treatments, will enable physicians toincreasingly detect, and treat, more silent aneurysms before problemsarise.

Currently, neurovascular aneurysms are treated via a limited range ofmethods. The potential benefits of current aneurismal treatments oftendo not outweigh the risks, especially for patients whose remaining lifeexpectancy is less than 20 years.

The original aneurysm treatment, neurosurgical clipping, a highlyinvasive and risky open surgery, remains the most common treatment forneurovascular aneurysms. Under general anesthesia, a surgeon performs acraniotomy, the removal of a section of the skull, gently retracts thebrain to locate the aneurysm, and places a small clip across the base,or neck, of the aneurysm, blocking the normal blood flow from enteringthe aneurysm. After completely obliterating the aneurysm with the tinymetal clip, the surgeon secures the skull in its original place andcloses the wound. The risks of a craniotomy, including the potential forfurther injury to the brain and additional neurological defect, areexacerbated in patients with a recent brain injury as well as in elderlyor medically complicated patients.

In 1995, following the pioneering work of Dr. Fernando Vinuela and Dr.Guido Guglielmi, the FDA approved an endovascular aneurismal treatment:“coiling.” In this procedure, an interventional radiologist guides acatheter from the femoral artery, through the aorta, and into thecerebral vasculature, via either the carotid or vertebral artery, untilit reaches the aneurysm. Embolic coils, small spring-like devicestypically made of platinum, are then threaded through the catheter andpacked into the aneurysm until enough coils are present to limit bloodflow into the aneurysm. This process, embolization, works by reducingblood circulation in the aneurysm, thereby triggering a thrombus. Byconverting liquid blood into a solid, coils reduce the danger of theaneurysm leaking or rupturing.

The introduction and continued evolution of the endovascular coilingprocess has certainly advanced less-invasive aneurismal treatment, butthe coiling process has limitations. Strong forces, generated byinterluminal flow around and into the aneurysm, often compacts, shifts,or partially dislodges the volume of coils left in the aneurysm. Aportion of a coil that prolapses out of the aneurysm neck can lead toserious and adverse consequences (e.g. clot formation, calcification, orother hardening and filling of the artery), and create difficulties inreaching the aneurysm for future treatment.

Recanalization, the reformation of an aneurysm at its neck, occurs inapproximately 15 percent of coiled aneurysms and in nearly 50 percent ofcoiled “giant” aneurysms. Since coiling does not protect the neck of theaneurysm, a coiled aneurysm risks recanalization, which may lead tofuture rupture and the need for repeat treatment(s). Furthermore, coilscreate what is known as the mass effect: the permanent lump of coilscontained within the aneurysm that maintain an undesirable pressure onthe surrounding brain tissue.

The coiling process only works effectively in some aneurysms,specifically small-necked aneurysms where the coils are more likely tostay securely in place within the aneurysm. In wide or medium-neckedaneurysms, coils may protrude or prolapse into the parent vessel andcreate a risk of clot formation and embolism.

In order to combat this design deficit, physicians have begun usingstents to improve the effectiveness of coiling. With stent-assistedcoiling, a stent lines the arterial wall, creating a screen that securesthe coils inside the aneurysm. These stents are generally self-expandingand have a low surface density to make them deliverable. Thus, the stentitself does not limit flow into the aneurysm sufficiently to trigger athrombus in the aneurysm. However, even these low surface density stentsrun a significant risk of blocking perforator arteries, creatingunpredictable damage to other parts of the brain. Additionally, anystent in the parent artery creates a risk of clot formation in theartery.

To prevent these dangers, the use of an implantable device that coversonly the neck of the aneurysm with a greater percent solid area wouldmore effectively restrict blood circulation into the aneurysm, trigger athrombus (the solidification of liquid blood within the aneurysm), andeliminate the danger of leak or rupture. Ideally, after formation of thethrombus, the aneurismal sac will shrink as the thrombus is absorbed,further reducing the chance of leak or rupture of the aneurysm, whilealso reducing pressure on the surrounding tissue. Coils or other deviceswhich remain in the aneurysmal sac tend to maintain the originalaneurysm volume, and thus the aneurysm continues to exert pressure onthe surrounding tissue.

Several additional types of devices designed to limit blood flow into ananeurysm have been described previously, yet none have beencommercialized, or approved by the FDA. In these methods, blood flowinto the aneurysm is limited to the degree necessary to form a thrombusin the aneurysm without filling the aneurysm with coils, a solidifyingagent, or other introduced matter. This type of solution often uses astent, or stent-like device, in the parent artery. However, unlikestents used to hold coils in place, the surface density of these stentssufficiently limit blood flow into the aneurysm and encourage thrombusformation. For example, U.S. Pat. Nos. 6,527,919; 6,080,191; 6,007,573;and 6,669,719 discuss stents that use methods involving rolled, flatsheets, and U.S. Pat. No. 6,689,159 discusses a radially expandablestent with cylindrical elements where expansion occurs when the stressof compression is removed. Most stents manufactured with a high-percentsolid area have limited longitudinal flexibility, tend to have a largedelivery diameter, and have an unacceptable probability of blockingperforator arteries, and thus limiting the number of aneurysms they canreach and treat. Additionally, since these methods require a straightparent artery, they will not work at the primary location of mostaneurysms: bifurcations, the division of a single artery into twobranches. The micro-pleated stent assembly of U.S. Patent PublicationNo. 2006-0155367 by Hines describes a stent for endovascular treatmentsthat has many advantages over other methods of treating aneurysms.However, this high surface area stent cannot be used to treat aneurysmsnear side branch or perforator arteries. Even though a micro-pleated, orother neurovascular stent can be patterned with a relatively dense patcharea designed to cover the neck of the aneurysm, a micro-pleated stent,or other thin-strutted device that covers artery surface beyond theaneurismal neck, runs a significant, and often unpredictable, risk ofrestricting blood flow to a smaller, branch artery.

Other methods that artificially solidify aneurysms have been describedpreviously. For example, U.S. Pat. No. 6,569,190 discloses a method fortreating aneurysms that fills the aneurismal sac with a non-particulateagent, or fluid, that solidifies in situ. This process leaves anundesirable side effect: a permanent, solidified lump cast in the volumeof the aneurysm. The filling agent also risks leaking, or breaking offinto, the parent artery, thereby creating a risk of embolus formation.

Previously described methods fill the aneurismal sac with a device orportion of a device. For example, U.S. Patent Publication No.2006-0052816 by Bates et al., describes a device for treating aneurysmsusing a basket-like device within the aneurysm that engages the innersurface of the aneurysm and blocks flow into the aneurysm. Similarly,U.S. Pat. No. 6,506,204 by Mazzocchi fills the aneurysm with a wire meshdevice that also attempts to captivate the neck of the aneurysm. Thedevices described by Bates et al., Mazzocchi, and similar devices do notallow the aneurysm volume to shrink and therefore do not lessen pressureon surrounding brain tissue. Such devices depend on an accurate fitwithin the inner geometry of the aneurismal sac, which is usually quiteirregular and difficult to determine, even with advanced imagingtechniques. If sized inaccurately, these devices will not completelyfill the aneurysm nor seal the neck of the aneurysm, causingrecanalization of the aneurysm from the strong lateral forces of theblood. The Mazzocchi device provides no possibility of contouring thepart of the device that remains in the parent artery to the arterialwall. Even the smallest amount of material extending into the parentartery runs an unacceptable risk of clot formation and resultingembolism. The Bates et al. device does not adequately protect theaneurysm neck, which may cause an unwanted expansion of the aneurismalneck and sac that risks leak or rupture. Due to these describedlimitations, among other practical concerns, aneurysm treatment devicessuch as those described by Bates et al. and Mazzocchi have receivedvirtually no commercial interest.

Other devices that bridge the neck of an aneurysm have been described.For example, U.S. Patent Publication No. 2003-0181927 by Wallacedescribes a neck bridge used to hold an embolic agent within theaneurysm. Wallace makes no provision to captivate the neck of theaneurysm and thus relies on filling the aneurysm with a particulateagent, liquid embolics, or coils in order to secure the device in place.This type of aneurysm treatment does not eliminate the mass effect onsurrounding brain tissue. Aneurysm neck bridge solutions describedpreviously, including Wallace, that do not permanently engage the innersurface of the aneurysm must rely on some internal, or external, meansin which to hold the neck bridge in its final position. For example,U.S. Patent Publication No. 2006-0167494 by Suddaby attempts to leavesome space in the aneurysmal sac that would allow the sac to shrink overtime, thereby lessening the mass effect. Suddaby, and similar designs,necessarily rely on an activation mechanism or restraining means to holdthe device shape after deployment. Such mechanisms concern physiciansfor many reasons. Specifically, their size and complexity limitsusefulness in the tiny and complex neurovascular anatomy. Additionally,springs or other internal restraining mechanisms risk puncturing theextremely fragile aneurysm neck or sac, which could result inpotentially disastrous consequences. Suddaby does not describe, ordisclose, any mechanism that holds the device in the described deployedshape, nor does it describe how the device is disconnected from thedelivery system. Suddaby fails to provide a workable design, describinga physically impossible transition from an initial delivery shape to afinal deployed shape, with no explanation of the mechanisms or forcesinvolved. The need, therefore, remains for an aneurysm exclusion devicethat can be reliably delivered and deployed to seal the neck ofneurovascular aneurysms, in a maimer that prevents recanalization of theaneurysm, that eliminates the mass effect, and that poses only a minimalrisk of inflicting damage to the aneurismal sac, neck, or parent artery.

As a result of the previously stated factors, the current technologiesand devices ineffectively treat most aneurysms. The present invention,however, overcomes the limitations of the current technologies anddevices and thereby provides a new hope for the safe, simple, andeffective treatment of aneurysms.

BRIEF SUMMARY OF THE INVENTION

The current invention details an exclusion device and endovascularcatheter-based delivery system. The device, when deployed in a lumen ororifice, reduces the flow of fluid past the device. In an illustrativeembodiment, the device is delivered endovascularly to the neck of ananeurysm and deployed to block the neck of the aneurysm, therebyreducing blood flow into the aneurysm. The deployment leaves the parentartery fully open and does not block perforator arteries that may existnear the aneurysm. In addition, the present invention treats aneurysmsat bifurcations and aneurysms located on the side of an artery.

The exclusion device of the present invention, a thin-walled, ductileshell, transitions between an initial as-manufactured shape, a compacteddelivery shape, a pressure expanded shape similar to the as-manufacturedshape, an evacuated crushed shape, and a final balloon-contoured shape.When deployed at the neck of an aneurysm, the exclusion device reducesblood circulation into the aneurysm, triggering a thrombus in theaneurysm that starts the healing process.

The novel balloon-like device is preferably an extremely thin ductileshell that includes an aneurysm lobe, a waist, and an artery lobe. Thelobe/waist design, combined with the material properties of the device,insures that a vacuum collapse of the device results in the appropriateshape (i.e. the two lobes collapse onto each other and captivate theneck of the aneurysm).

For delivery, the exclusion device is attached, in an airtight fashion,to the distal end of a delivery tube. The delivery tube, which transmitsthe necessary pressure to expand and collapse the device, may beconstructed of any material suitable for advancing the device through acatheter within a body lumen to the deployment site. Optionally, a thin,tubular protection sheath may cover the device as it is advanced to thedeployment site. The protection sheath may be operably extended, throughthe outer catheter tube, outside the body so that the sheath may bepulled back, exposing the exclusion device prior to expansion. Thisrelease from the outer sheath may occur in controlled stages, allowingthe device to be expanded one lobe at a time: the aneurysm (distal) lobefirst while the sheath restrains the artery lobe.

If no protective sheath is used, an outer catheter tube may restrain theartery lobe during expansion of the aneurysm lobe. This expansion of theaneurysm lobe may aid in properly deploying the device by facilitatingseating of the expanded aneurysm lobe against the neck of the aneurysm,leaving the device in the proper position for full inflation of theartery lobe.

After expansion of both the aneurysm and artery lobes, the device iscollapsed by applying vacuum pressure transmitted through the deliverytube. External pressure collapses the two lobes, captivating the neck ofthe aneurysm between the two collapsed lobes.

Following disconnection of the exclusion device, the delivery tube, andany remaining hardware (with the possible exception of the guidewire),is removed. The final step in the deployment could use expansions of aballoon catheter, advanced over a guidewire, in the lumen of the artery,to push any portions of the exclusion device that may be remaining inthe artery lumen, to the artery wall, completely flattening the arterylobe and stem of the device while fully opening the artery.

Unlike any other devices for treating aneurysms, the exclusion deviceshell manufactured according to the present invention, holds itscontoured shape without any means of internal or external restraint dueto the foil-like nature of its thin, ductile, metal composition. A thin,plastic exclusion device shell, or shell constructed of any material ormaterials that does not completely hold its balloon contoured shapeflush against the arterial wall may use internal adhesion to retain itsfinal, contoured shape.

An exclusion device, manufactured and deployed as described by thisinvention, may be used to treat a patient with an aneurysm which has asignificant leak or which has ruptured completely. The exclusion deviceis able to occlude a ruptured aneurysm where significant forces existdue to flowing blood. The present invention provides a treatment optionin these crucial cases because of its novel characteristics, whichenable a secure, solid seal to be reliably placed over the neck of aruptured aneurysm. Additionally, the simplicity and speed with which anexclusion device may be deployed make this invention a unique and usefultreatment option. This exclusion device, once deployed across the neckof a ruptured or leaking aneurysm, provides an immediate barrier toflowing blood, with no need to wait for thrombus formation, as is thecase with coiling. Additionally, coiling is usually not an option in aruptured aneurysm due to the risk of coils migrating through the hole inthe aneurysmal sac and into the brain cavity.

The exclusion device and delivery process may be used to close, orblock, other body lumens or orifices. For example, the device may beused to close a Patent Foramen Ovale (PFO) or various fistulas. Withminor modifications within the scope of this invention, the device maybe used to temporarily, or permanently, close fallopian tubes.

Various fabrication and delivery options within the scope of thisinvention may be used to tailor the device for specific conditions.Overall size of the device, and the relative size and shape of the lobesand waist, may be tailored to fit the treatment of any aneurysm ordefect.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-10 depict delivery system option one in which the exclusiondevice is compacted around, and slides over, a guidewire for delivery.

FIG. 1 shows a cross-section of an exclusion device shell and mandrel.

FIG. 2 depicts a flattened exclusion device attached in an airtightfashion to a delivery tube.

FIG. 3A shows a cross-section of a flattened exclusion device with aguidewire.

FIG. 3B shows a cross-section of a flattened exclusion device foldedaround a guidewire.

FIG. 3C shows a cross-section of a flattened exclusion device rolledaround a guidewire.

FIG. 4 depicts an exclusion device assembly in an aneurysm at anarterial bifurcation prior to inflation.

FIG. 5 depicts an exclusion device, reformed by pressure expansion, atthe neck of an aneurysm.

FIG. 6 depicts an evacuated and collapsed exclusion device shell in theneck of an aneurysm.

FIG. 7 depicts a collapsed exclusion device shell following detachmentfrom a delivery tube.

FIG. 8 depicts a balloon contouring of an exclusion device shell to anarterial wall.

FIG. 9 shows a cross-section of an exclusion device shell and mandrelwith bellows.

FIG. 10 depicts an exclusion device with bellows, reformed by expansion,at the neck of an aneurysm.

FIGS. 11-18 depict delivery system option two which uses an additionalcatheter tube outside a delivery tube.

FIG. 11 depicts an aneurysm at a bifurcation with an inserted guidewireand an outer catheter tube advanced over a guidewire.

FIG. 12 depicts a compacted exclusion device advanced from an outercatheter tube at the neck of an aneurysm.

FIG. 13 depicts an exclusion device with an aneurysm lobe expanded inthe aneurysm while an artery lobe is restrained with an outer cathetertube.

FIG. 14 depicts an exclusion device with an aneurysm lobe expanded inthe aneurysm while an artery lobe is restrained with the protectivesheath.

FIG. 15 depicts an exclusion device, with an expanded aneurysm lobeseated against the inner neck of an aneurysm, in position for fullexpansion.

FIG. 16 depicts a fully expanded exclusion device.

FIG. 17 depicts a vacuum collapsed exclusion device.

FIG. 18 depicts disconnection of an exclusion device from a deliverytube by using the distal tip of an outer catheter tube to shear shellmaterial, leaving the stem glued to a delivery tube for removal from abody.

LIST OF REFERENCE NUMERALS

10 Exclusion device

20 Mandrel

30 Waist of exclusion device

40 Aneurysm (distal) lobe

50 Artery (proximal) lobe

60 Stem

70 Axis of rotation

80 Bellows section

110 Flattened exclusion device shell

130 Internal void

140 Folded shell

150 Rolled shell

155 Compacted exclusion device

200 Delivery tube

210 Disconnection pushed wire

220 Guidewire guide

300 Guidewire

310 Flexible tip of guidewire

410 Parent artery

420 Smaller arteries distal to a bifurcation

430 Aneurysm

435 Aneurysm neck

460 Protective sheath

500 Outer catheter tube

600 Balloon catheter

DETAILED DESCRIPTION OF THE INVENTION

The current invention provides an exclusion device and novelcatheter-based endovascular delivery and deployment methods. In theillustrative embodiments depicted in FIGS. 1-18, an exclusion device 10is delivered to an aneurysm 430, positioned at the neck 435 of theaneurysm, and deployed, thereby blocking the neck of the aneurysm andreducing blood flow into the aneurysm 430. The deployment leaves theparent (proximal) artery 410 fully open.

At a bifurcation, the proximal artery 410 splits into two smallerarteries 420 as shown in FIGS. 4-8, and FIGS. 11-18. The deployedexclusion device does not block side branch arteries that may exist nearthe aneurysm. Aneurysms at bifurcations (as shown in FIGS. 4-8 and FIGS.11-18) and aneurysms on the side of an artery (as shown in FIG. 10) maybe treated. The exclusion device, deployed to cover the neck of ananeurysm, reduces blood flow into the aneurysm and triggers a thrombusin the aneurysm that starts the healing process.

The exclusion device of the present invention is a thin-walled,pressure-vessel shell. The device transitions between an initial asmanufactured shape, a compacted shape, a pressure expanded shape similarto the as manufactured shape, an evacuated crushed shape, and a finalballoon-contoured shape. The as manufactured shape of the exclusiondevice 10 is determined by the shape of the sacrificial mandrel 20 asdepicted in FIGS. 1 and 9. The compacted shape will vary slightlydepending on the chosen compaction method. One preferred compactionoption is depicted sequentially in FIGS. 2, 3A, 3B and 3C, which showthe exclusion device 10, flattened 110, folded 140, and rolled 150. Theexclusion device may alternatively be compacted in a generally radialmanner 155, as depicted in FIGS. 4 and 12. Positive pressure transmittedthrough a delivery tube 200 expands the device 10 to a shape resemblingits as manufactured shape, as is depicted in FIG. 5 and 16. Vacuumpressure transmitted through a delivery tube 200 is used to transformthe exclusion device to a collapsed shape as depicted in FIGS. 6, 7, 17and 18. A balloon catheter expanded in the parent artery results in afinal balloon contoured shape as depicted in FIG. 8.

FIGS. 9 and 10 depict an optional configuration of the exclusion devicethat includes a bellows section 80. The bellows 80 facilitate placementin an aneurysm on the side of an artery as shown in FIG. 10. In FIG. 9and 10, two lobes are shown in the bellows section but more and smallerlobes may be used.

The delivery tube 200 is designed to accommodate the attachment of theexclusion device shell 10, in an air tight fashion, to its distal end.The balloon-like exclusion device shell 10 includes an aneurysm (distal)lobe 40, a waist 30, and an artery lobe 50.

The device 10 requires some form of compaction for delivery. Severalcompaction methods have been tested and many other possible methodsexist. Flatten, fold, and roll (as depicted in FIGS. 3A, 3B and 3C)compacts the device into a form that opens at a lower pressure. Thismethod, however, may not be compatible with a separate expansion of theaneurysm lobe prior to the full expansion of the device. If flattened,folded, and rolled, both lobes of the device preferably unroll togetherand expand simultaneously. Rolling may be the most effective method forcaptivating the guidewire 300, although the guidewire may be captivatedin a radially compacted 155 device 10 as well. The compaction methodused must be compatible with the planned deployment method.

For deployment, a guidewire 300 is first advanced into the aneurysm 430.Standard angiographic, procedures may be used to view the arteries andaneurysm. The exclusion device 10 is located with its waist 30 in linewith the neck 435 of the aneurysm 430. Positive pressure transmittedthrough the delivery tube 200 expands the exclusion device.

In delivery method option one, as depicted in FIGS. 2-10, the guidewire300 is outside of the delivery tube 200 and may be threaded through aguidewire guide 220 at the distal end of the delivery tube 200. Theguidewire guide 220 reduces stress on the rolled 150, or otherwisecompacted 155, device during the delivery process. In this deliverymethod, the device is preferably flattened 110, folded 140, and rolled150, around the guidewire 300 as shown in FIGS. 2, 3A, 3B, and 3C. Thedevice may also be radially or otherwise compacted 155, without beingrolled 150, around the guidewire 300. Compacting the device around theguidewire 300, without rolling 150, may be necessary if the aneurysmlobe 40 of the device is to be expanded separately from the artery lobe50. The guidewire 300 slides freely in the tubular channel formed by therolled 150, or otherwise compacted 155, device 10. A cylindrical,temporary aid may be used to provide a controlled clearance between theguidewire 300, and the compacted exclusion device 150 or 155, duringassembly. To deploy the exclusion device, the flexible guidewire tip 310is first advanced into the aneurysm. In this delivery option one, thedevice is advanced over the guidewire 300 as the delivery tube 200 isadvanced. The rolled 150 or otherwise compacted 155 exclusion device maybe located with its waist 30 in line with the neck 435 of the aneurysm430 as shown in FIG. 4. Positive pressure in the delivery tube 200expands the device.

In delivery method option two, as shown in FIGS. 11-18, the compactedexclusion device 155 is advanced through an outer catheter tube 500after the guidewire 300 is removed. Delivery method two may also use anexclusion device that is rolled 150 as a means of compaction, however,the device would not be rolled around a guidewire 300 since with thisdelivery method, the guidewire 300 is removed before the device ispushed through the outer catheter tube 500. Fluid pressure and fluidflow may be applied at the proximal end of the catheter tube 500 tolubricate and help carry the device 10 and delivery tube 200 through thecatheter tube 500. The delivery tube 200, with the device 10 attached tothe distal end, is pushed through the outer catheter tube 500 to thedeployment site. Unlike delivery option one, the guidewire is notavailable to stabilize the device position at the aneurysm neck duringdeployment. When the deployment is generally straight into the aneurysm,as shown in FIGS. 1-8 and 11-18, option two deployment is relativelystraight forward. However, where a straight deployment is not possible,as shown in FIG. 10, small catheters with pre-shaped tips or catheterswith steerable tips may be used to direct the device into position atthe neck of the aneurysm. Bent tip and steerable catheters are known inthe art.

An additional option for retaining the catheter tip in the aneurysmafter guidewire removal uses a flexible, but straight-tipped, catheter.This method places the tip of the catheter within the aneurismal sac anduses the wall, or neck, of the aneurysm to support the catheter's distalend, retaining the catheter tip in the aneurysm for exclusion devicedeployment. If a deployment method is chosen where the opening of thecatheter is within, rather than at the neck of, the aneurysm, thetechnique depicted in FIGS. 13-15 with delayed artery lobe expansionwould be used.

In both delivery methods described above, it may be advantageous tofirst apply positive pressure into the exclusion device when only theaneurysm (distal) lobe 40 and waist 30 of the exclusion device are freeto expand (as shown in FIGS. 13-15). To accomplish this technique, theartery lobe 50 may be restrained as the aneurysm lobe 40 is expanded. Indelivery method one, since there is no outer catheter tube 500, aprotective sheath 460, or another method, could be used to restrain theartery lobe. In delivery method two, either the protective sheath 460 orthe outer catheter tube 500 may be used as a means of restraining theartery lobe (as shown in FIGS. 13 and 14). This allows the expandedaneurysm (distal) lobe 40 to hold the device in the aneurysm (as shownin FIG. 15), while the outer catheter tube 500, or protective sheath460, is pulled proximally, releasing the artery lobe 50 of the device.When the sheath 460, or outer catheter tube 500, is pulled proximally asufficient distance from outside the body, the device is unconstrainedand in position for full expansion and subsequent collapse. Thecylindrical portion of the protective sheath 460 may be only long enoughto cover the exclusion device, and string, or strings, which may beconnected operably to the cylindrical section, and may extend to theoutside of the body to facilitate controlled pull back of the sheath. Ifnecessary, the pressure in the device could be reduced slightly beforethe outer catheter tube 500, or protective sheath 460 (if used), is slidoff of the artery lobe 50 of the exclusion device. Additionally, thesheath 460 may function to protect the exclusion device and reducefriction during movement within the catheter 500. Other methods may beused to insure that the aneurysm lobe 40 expands before the artery lobe50. For example, the artery lobe may be thicker or more tightlycompacted to insure that the aneurysm lobe 40 opens first, at a lowerpressure.

If using delivery method one, the guidewire 300 would be removed fromthe aneurysm (as shown in FIG. 5 and FIG. 10) before the exclusiondevice is fully expanded. If using delivery method two, the guidewire300 may be removed from the aneurysm after the outer catheter tube 500is in place within, or just outside, the aneurysm neck but before thedevice is fully expanded—or alternatively, before the device is pushedthrough the outer catheter tube 500.

After the exclusion device is positioned and expanded (as shown in FIGS.5 and 16), the device subsequently is collapsed by applying vacuumpressure through the delivery tube 200 (as shown in FIGS. 6 and 17).External pressure collapses the two lobes of the exclusion device,captivating the neck 435 of the aneurysm between the two collapsedlobes.

The exclusion device may be disconnected from the delivery tube 200 in avariety of ways, many of which will be, or will become, apparent tothose skilled in the art. The disconnection options described here areapplicable to either delivery method one or two. One option todisconnect the exclusion device from the delivery tube 200 involvesadvancing a pushed wire 210 inside the delivery tube and shearing theexclusion device from the delivery tube. Another option simply rotatesthe delivery tube, shearing off the stem of the device in the process.

Another method for disconnection uses a catheter tube 500 outside thedelivery tube 200 to shear off the deployed exclusion device shell nearits stem, freeing the device from the delivery tube 200 as shown in FIG.18. For this method, the distal tip of the protective sheath 460 or thedistal tip of the outer catheter 500 could be used to shear the deviceshell where the stem 60 connects with the proximal lobe 50 of the device10. The outer tube will be maintained in place to hold the collapsedshell in place while the delivery tube 200 is pulled back to shear thethin shell material and disconnect the device 10 from the delivery tube200.

Other disconnection systems using electrochemical dissolution or heat toremove or destroy an element in the connection chain may be used. Afterdisconnection of the exclusion device, the delivery tube 200 and thedisconnection pusher wire 210 are removed from the body. The final stepin the deployment (as shown in FIG. 8) of the exclusion device advancesa standard balloon catheter 600 over the guidewire 300. The balloon atthe distal end of the catheter is located, and expanded, pushing anyportions of the artery lobe 50 and stern 60 of the exclusion device 10against the artery wall, flattening the device and fully opening theartery. Multiple balloon expansions may be necessary, especially whenthe aneurysm is located at a bifurcation. If the exclusion device isconstructed from a thicker, or stiffer, material, it may be impossibleto collapse the exclusion device with available negative pressure. Inthis case, the aneurysm lobe may be left in its expanded state, and theartery lobe may be collapsed and then contoured using a ballooncatheter.

The following description elucidates, with varied characteristics, thegeneral steps, and options, in the design, and manufacturing, ofexclusion devices and the situations where the present invention may beused.

It is anticipated that a number of shapes, and sizes, of exclusiondevices would be manufactured for various applications. The range oftypes, and shapes, of the exclusion device would be determined by theneeds of each particular application. The device may be constructed fromrubber, plastic, PARYLENE™, gold, platinum, or other ductile metals,singularly, or in combinations.

When using the exclusion device to exclude an aneurysm from thecirculatory system, the appropriate waist 30 diameter of the exclusiondevice 10 would be approximately 1 mm smaller than the neck 435 of theaneurysm requiring treatment. The diameters of the two lobes may beapproximately 2 mm larger than the neck 435 of the aneurysm. The twolobes need not be symmetrical: each lobe's respective shape, and sizes,is variable and determined by the design, and machining, of anappropriate mandrel.

The stem 60 design, and opening size, are also variable. In order tofacilitate an air tight, and appropriately strong, seal between thedelivery tube 200 and the exclusion device stem 60, the stem 60 size,including length and diameter, will be based upon the size, and design,of the delivery tube 200. If the stem is to be glued to the inner wallof the delivery tube, the diameter for the stem 60 of the mandrel 20will be equal to the inside diameter of the delivery tube 200, minus twotimes the thickness of the device wall. If the device is formed byelectroplating, extra stem 60 length will be left on the mandrel forelectrical connection. Excess stem 60 length will be removed afterelectroplating in order to expose the mandrel 20 for dissolving. Ifcoating the mandrel with plastic or other non-electroplated material,the excess coating and stem will be trimmed to the final stem length,exposing the mandrel for removal.

The mandrel material must possess appropriate physical characteristicsincluding, but not limited to, the ability to be machined into thedesired shape and sacrificially dissolved within the exclusion deviceshell. Brass and copper have been found to work well with gold,platinum, and PARYLENE™ exclusion shells. The mandrel may be fabricatedon a computer controlled lathe.

In preparation for electroplating, a metal stern extension is solderedonto the stem of the mandrel. The extension provides both an electricalcontact and a mechanical support for the mandrel in the electroformingbath. Next, a resist mask is applied over the solder joint, forming aband of resist that controls plating at the area, restricting platingspecifically to the mandrel and the portion of its stem not covered byresist. The resist band allows plating slightly beyond the final stemlength. The stern extension, with attached mandrel, is then placedvertically into a plating bath to a depth that covers the mandrel and aportion of the stem extension. This alignment is accomplished byaligning the surface of the bath with the resist band.

Using standard electroplating techniques, gold, or other metals, iselectroformed on the mandrel. Typically, the mandrel is rotated aboutits axis during plating. Exclusion devices of the present invention,designed to treat neurovascular aneurysms, typically have anelectroplated metal shell between 3 and 10 microns thick. For largerdevices, the electroplated metal thickness can be increased accordingly.The thickness, design, material, and material properties of theexclusion device may be modified in order to allow collapse of theexclusion device with a vacuum.

After electroplating, the excess stem is trimmed by excising the steinextension below the solder joint and grinding excess material to thedesigned stem length.

In order to dissolve the sacrificial mandrel, a dissolving liquid needsto be introduced into the stem of the exclusion device and circulatedthroughout the exclusion device. One method for removing the mandreluses vacuum cycling, with controlled pressure ramps, to circulate thedissolving liquid into the shell through the stem by controlledexpansion and contraction of gas generated as the mandrel dissolves.

The following example uses gravity to create the fluid exchange insidethe exclusion device. If a Copper or Brass mandrel is used, anappropriate reservoir is filled with 500 ml of dissolving liquid, ⅓strength (by volume) nitric acid (HNO₃). If the mandrel is constructedfrom a different material, a liquid known to selectively dissolve thatmandrel material should be used.

With stem facing up, the mandrel is placed in a TEFLON™ fixture. Thefixture, and mandrel, are placed in a catch basin, composed of materialsuitable for containing the dissolving liquid. A stainless steelhypodermic needle is connected to a TYGON™ tube that is in turnconnected to a reservoir containing the dissolving solution. The needleis then placed in the fixture directly above the exclusion device stem.The reservoir is elevated an appropriate distance above the needle inorder to facilitate the use of gravity to obtain the correct pressure tocreate the desired rate of flow.

After a sufficient amount of the mandrel has been dissolved, the needleis lowered into the stem so that the dissolving liquid flows into theinterior of the exclusion device shell. The initial mandrel removal fromthe stem, however, could be accomplished by immersion of the exclusiondevice in a container of the dissolving liquid. Once the stem is partlyopen, the needle is placed in the stem to complete the mandrel removal.

When gas evolution from the shell has ended, the shell is cleaned anddried. One rinsing option leaves the needle in place in the shell, withthe tubing connected to a high-purity water reservoir that circulateswater into the mandrel. Other methods may be used provided that aminimum volume of high purity water equal to about 100 times the volumeif the shell is passed through the mandrel free shell.

Next, with the exclusion device stem pointing down, the tubing may beconnected to a low-pressure dry-air supply (3 psig) in order to removeall excess water from the exclusion device shell, completely drying theshell. This rinsing and drying process may be accomplished in anyfunctional manner known to those skilled in the art. The water rinse andair purge procedures should be repeated at least two times. The metalexclusion device shell can then be dried in an oven at approximately110° C. To increase the ductility of a metal exclusion shell, the shellmay be annealed in a high temperature oven. For example, a gold shellshould be annealed at temperature between about 200° C. and about 500°C.

A porous surface layer for storage and elution of substances including,but not limited to, drugs, proteins, cells, genetic material, livingtissue, and/or growth factors, etc. could be added to all, or part, ofthe device using the methods of U.S. Pat. No. 6,904,658 (PROCESS FORFORMING A POROUS DRUG DELIVERY LAYER to Richard A. Hines). The porouslayer could be used to improve endothelization with, or without,delivery of a substance. A porous layer of this method could be used todeliver biological material(s) in addition to, or in place of, a drug.

The entire exclusion device could be manufactured with varying degreesof porosity by producing an exclusion device with either small or largeholes. If the holes are small, the shell may be pressure expanded andcollapsed without the need to plug the holes. The porous exclusiondevice shell, with either small or large holes, could be covered, orpainted, with a material that would plug the manufactured holes. Afterdeployment in the body, the plug material would dissolve at apredetermined rate, leaving a mesh-like shell in the artery that wouldfacilitate rapid migration of tissue cells through, and across, thesurface of the exclusion device to improve endothelization.

An exclusion device with small holes, typically between 5 and 25microns, could be manufactured using high-current electroplating andwould allow the shell to expand and collapse in the inventive mannerpreviously described.

Larger holes, typically between about 25 and 100 microns, could beuseful in assisting the endothelialization of arterial tissue to theexclusion device. An exclusion device manufactured with larger holescould use dissolvable, or biodegradable, plugs that enable pressure toexpand and collapse the exclusion device. A porous shell with largeholes would still sufficiently reduce flow into the aneurysm to triggera thrombus in the aneurysm and start the healing process.

Various methods could be employed to produce an exclusion device withlarge holes. The exclusion device could be a woven mesh-shape over themandrel. The porous shell net could be formed from gold, or anothersuitable, wire or fiber materials. One method could form a porous shellby employing heat, and/or pressure, to bond fibers over a mandrel. Thewire shell could be woven, or knitted. Photoimaging andelectroforming—as taught in U.S. Pat. No. 6,019,784 (PROCESS FOR MAKINGELECTROFORMED STENTS to Richard Hines) and U.S. Pat. No. 6,274,294(CLYINDRICAL PHOTOLITHOGRAPHY EXPOSURE PROCESS AND APPARATUS, also toHines)—could be used to produce the large holes.

Laser exposure, or a clam shell mask, could also be used to selectivelyexpose photoresist onto the exclusion device that, after development,would leave spots of resist, thereby creating holes in the electroformedshell. Complete shells could be electroformed and then laser drilled toproduce the holes. A thick, electroformed shell could be laser drilledand then cut in half to create the clam shells for resist exposure.

In yet another method, photoresist could be sprayed, in a non-continuouslayer, onto the device, creating spots of resist that would form holesin the electroformed shell.

The entire exclusion device, or parts thereof, may be manufactured fromdissolvable, or biodegradable, materials. For purposes of thisspecification, “dissolvable” is defined as a substance that changes froma solid to a form with greater disbursement when placed in contact withthe fluids of the body, and “biodegradable” is defined as a substancethat is chemically degraded, or decomposed, when placed in contact withthe fluids of the body.

For example, a shell with larger holes could be manufactured from amaterial that biodegrades within a time period ranging from a few daysto a few months, and the holes in the shell could be filled with asimilar, or different, material that dissolves or biodegrades at aquicker rate, on the order of a few minutes to several days, than thematerial used to manufacture the shell. The material used to fill theholes in the shell is needed to maintain the pressurized vesselfunctions for both expansion and collapse of the exclusion device.Aneurysm treatment research indicates that in a post-deploymentenvironment the exclusion device must maintain a minimum of only 30%solid coverage over the neck of the aneurysm. These parameters, ofcourse, may vary slightly depending upon the intended use of theexclusion device. Following deployment, the dissolvable or biodegradableportions would separate from the exclusion device and safely enter theblood stream. The remainder of the exclusion device could either remainpermanently in the aneurysm or biodegrade and/or dissolve completelyafter a predetermined period of time. Once a thrombus is formed in theaneurysm, and an appropriate amount of endothelial tissue has grown overthe neck of the aneurysm, the exclusion device has accomplished itspurpose. If the exclusion device is manufactured from a biologicallyinert material, it may be left encapsulated in the endothelial tissue,or if the exclusion device is manufactured from a biodegradablematerial, its design facilitates gradual degradation, or absorption, inwhole, or in part. Any combination of biodegradable, dissolvable, orpermanent material(s) could be used within the scope of this inventionto manufacture the exclusion device.

To allow stem flexibility for delivery of the exclusion device 10 intoan aneurysm 430 located on the side of an artery 410, one embodiment ofthe present invention (FIGS. 9 and 10) includes bellows 80 formed in thestem 60. If the aneurysm position is such that a straight outer cathetertube would tend to spring, or fall, out of the aneurysm once the guidewire is removed from the aneurysm, an outer catheter tube 500 with apreshaped end could be used, and the tip, or some distal portion of theouter catheter tube, could be placed within the aneurysm, with a pointon the distal portion resting against the wall, or neck, of theaneurysm. In situations where the distal end of the outer catheter tubeis actually contained within the aneurismal sac, rather than at the neckof the aneurysm, it would probably be necessary to use the devicedeployment method depicted in FIGS. 15 and 16, inflating the aneurysmlobe separately, and prior to, the artery lobe expansion.

A liquid agent, with or without radiopacity, could be used to fill,expand, and collapse the exclusion device. A liquid agent, or fillmaterial, that solidifies after exclusion device collapse and ballooncontouring could aid in establishing the final exclusion device shape.This liquid agent would be particularly useful in PARYLENE™, or plastic,shelled exclusion devices. Additionally, the inside surface of theexclusion device, particularly if the exclusion device is constructedfrom PARYLENE™, plastic, or with a plastic inner lining, could beactivated by a solvent, or other solution, after placement, andexpansion, within the body, creating a tacky inner shell that causes theshell to stick to itself when vacuum collapsed and balloon contoured.

The exclusion device, and associated assembly, is designed forintraluminal delivery. The design characteristics of the invention allowthe exclusion device to be compacted to an exceptionally small size andbe more flexible during, and effective upon, delivery than previouslydisclosed aneurysm neck-covering devices. In particular, the device maybe manufactured, and delivered, as described herein in such a way thatenables use in the tiny, tortuous, and complex neurovascular anatomy.The numerous unique benefits, including the degree of safety, accuracy,and reliability in which this exclusion device can be realisticallydelivered deep into the tortuous arteries of the brain, make it bothnovel and useful.

In both of the two general delivery methods described herein, theexclusion device is connected, in an airtight fashion, to the distal endof a delivery tube 200. Depending upon the choice of disconnectionmethod, the exclusion device stem 60 may be slid into, or over, thedistal end of the delivery tube and then glued into place. Medical gradeLOCTITE™ 4011 has been used to successfully glue the exclusion device tothe delivery tube. The strength of the glue joint must be sufficient toallow pressurization, and evacuation, of the device but delicate enoughto be easily broken when the detachment pusher 210 is advanced to detachthe exclusion device. However, the glue joint should be extremely strongif disconnection of the shell requires shearing of the shell whileleaving the glue joint intact. Other methods, apparent to those skilledin the art, may be applied to leak-test the exclusion device and itsconnection to the delivery tube.

In delivery option one, an optional guidewire guide 220 may be used aspart of the delivery system. The guidewire guide 220, consisting of athin-walled tube, or ring, manufactured from a material with a lowcoefficient of friction to the guidewire, would be attached to thedelivery tube 200 near the distal tip of the delivery tube. The axis ofthe guidewire guide is parallel to the delivery tube and extends as athin-walled cylinder beyond the tip of the delivery tube to a distanceequal to, or less than, the distance that the waist of the exclusiondevice extends beyond the distal tip of the tube. The guidewire guidereduces stress on the rolled exclusion device by holding the guidewireadjacent to the delivery tube. The thin-walled cylinder that extendsbeyond the catheter tube reduces possible damage to the exclusiondevice, damage that could result from the relative movement between therolled exclusion device and the guidewire as the exclusion device isadvanced over the guidewire and into the aneurysm. To prevent entrapmentin the aneurysm when the exclusion device is expanded, the thin-walledcylinder should not extend beyond the waist of the exclusion device.

In delivery option one, the exclusion device is first gently flattened,forming wrinkles and folds in the shell (as shown in FIG. 2). Theflattened exclusion device shell 110 is then folded, and rolled, aroundthe guidewire 300 (FIGS. 3A, 3B, and 3C).

In both described delivery options, the guidewire is first advanced intothe aneurysm in a standard fashion. In the first delivery option, theouter catheter tube is then advanced over the guidewire to a positionjust inside of the aneurysm. In either delivery method, an optionalguide-catheter may be used to facilitate advancement of the exclusiondevice to a predetermined point in the neurovascular anatomy close tothe site of the aneurysm.

In delivery option one, the exclusion device is advanced over aguidewire and into the aneurysm. If the aneurysm lobe 40 is to beexpanded first, and separately, exact positioning is not crucial,provided that the lobe is expanded within the aneurysm. If both theaneurysm lobe 40 and the artery lobe 50 are to be expandedsimultaneously, the neck of the exclusion device should be alignedapproximately with the neck of the aneurysm 435. The novel devicegeometry, material properties, and controllable low-pressureinflation-based deployment system, provide self-alignment of the waistof the exclusion device within the neck of the aneurysm. A standardsyringe pump may be used to increase the pressure in the exclusiondevice, causing it to unroll. Prior to pulling back the catheter andcompleting the expansion, the exclusion device may be partially extendedfrom the outer catheter in order to expand the aneurysm lobe, but beforefully expanding the exclusion device, the guidewire 300 should beremoved from the aneurysm, leaving the tip of the guidewire 310 in theartery, distal to the aneurysm, so that it will be ready to guide aballoon catheter 600 to the site of the aneurysm. With the guidewireremoved from the aneurysm, a continued increase in pressure within theexclusion device will fully expand the exclusion device to itsas-manufactured shape. As the device expands, its shape will tend toauto align the waist of the device with the neck of the aneurysm.

Minor adjustments in the outer catheter tube positioning may benecessary in order to obtain the desired position of the exclusiondevice. When positioned properly, the expanded distal lobe of the devicewill be completely inside the aneurysm, the expanded proximal lobeinside the artery, and the waist of the device aligned with the neck ofthe aneurysm.

Next, the exclusion device shell should be evacuated and collapsed. Thedesign of the exclusion device ensures that external pressure collapsesthe exclusion device longitudinally, flattening both the aneurysm andartery lobes in a plane perpendicular to the axis of symmetry. Astandard syringe pump, or other method apparent to those skilled in theart, may be used to evacuate the exclusion device. As the pressure isreduced below atmospheric pressure, the device collapses. By reducingthe pressure to a minimum, the exclusion device fully collapses andlocks itself into the neck of the aneurysm.

Any of several existing, or discovered, methods may be used todisconnect the exclusion device from the delivery tube. Additionally,either of two device-specific novel disconnection methods may be used.In one novel method, the exclusion device stem 60 is attached to theinner diameter of the delivery tube 200, and while the delivery tube 200is held in position, a disconnection wire 210 is advanced through thedelivery tube until it contacts the glue-joint where the exclusiondevice stem 60 is attached to the delivery tube 200. As thedisconnection wire 210 is slowly advanced, the stem/delivery tube jointis severed. In a second novel disconnection method, the stem/deliverytube joint remains intact. The shell is sheared near the stem 60, andthe stem 60 and glue-joint are removed from the body. This method isaccomplished by using an outer tube 500, or sheath 460 (with thenecessary compressive strength), outside of the delivery tube 200. Whilethe outer tube 500 is held in stable position, in contact with theproximal surface of the device 10, delivery tube 200 is pulledproximally, as shown in FIG. 18. This shearing may also be accomplishedby holding the delivery tube 200 in stable position, while the cathetertube 500 is advanced distally. The tip of the outer tube 500 easilyshears the thin, ductile shell. The tip parameters of this “shearing”tube may be altered depending on the thickness, and type, of thematerial used to manufacture the exclusion device shell. This methodremoves the part of the shell material that is glued to the deliverytube 200, and the glue, leaving only the exclusion device material inthe body. With minor design modifications still within the scope of thisinvention, other disconnection systems using electrochemicaldissolution, or heat, to remove, or destroy, an element in theconnection chain may be used.

Following successful placement of the exclusion device, the deliverytube and detachment wire are disconnected from the device and removedfrom the body. To shape the device to its final deployed position, thepreviously collapsed artery lobe may be balloon contoured, tightlyconforming it to the arterial wall 420. This technique advances aballoon-catheter 600 over the guidewire 300 to the portion of the arterythat contains the aneurysm. The position of, and pressure inside, theballoon may be adjusted during single, or multiple, balloon expansions.The balloon gently forces the section of the exclusion device, which maybe partially obstructing the lumen, to the arterial wall. This devicecontouring technique is uniquely possible with the device of the presentinvention due to the novel physical characteristics of the device,including, but not limited to, its thin ductile wall.

With some material and thickness compositions used to manufacture theexclusion device, it may not be collapsible with available negativepressure. In this case, the aneurysm lobe may be left expanded, and theartery lobe could be collapsed, and flattened, using the ballooncatheter. Following collapse and flattening of the exclusion device, theballoon is deflated and removed from the body.

The outer catheter 500 tip may have at least one radiopaque marker toassist in positioning the exclusion device as it is pushed by thedelivery tube, through the outer catheter, to the deployment site. Ametal exclusion device with a shell at least 5 microns thick isradiopaque and clearly visible using standard detection procedures.Radiopaque markers may also be applied to the protective sheath 460 ifused during delivery.

The foregoing description of the present invention has been presentedfor purposes of illustration and description. Furthermore, thedescription is not intended to limit the invention to the form disclosedherein. Consequently, variations and modifications commensurate with theabove teachings, and the skill or knowledge of the relevant art, arewithin the scope of the present invention. The embodiment describedhereinabove is further intended to explain the best mode known forpracticing the invention and to enable others skilled in the art toutilize the invention in such, or other, embodiments and with variousmodifications required by the particular applications or uses of thepresent invention. It is intended that the appended claims be construedto include alternative embodiments to the extent permitted by the priorart.

1. An exclusion device comprising: a shell comprising at least two lobesseparated by a waist, wherein the shell is capable of containingpressure; a hollow stem connected to one lobe of the shell, wherein thestem communicates fluid pressure to the inside of the shell; and,wherein the shell is capable of transitioning from a manufactured shapeto a compacted cylindrical shape to a pressure-expanded shape to avacuum pressure-collapsed shape, wherein the vacuum pressure collapsereduces the two lobes to closely-spaced disks.
 2. The device of claim 1,wherein a material comprising the shell may be balloon-contoured withoutregaining a pressure-expanded shape.
 3. The device of claim 1, whereinthe shell has a thickness of about 3 microns to about 10 microns.
 4. Thedevice of claim 1, wherein the shell comprises a ductile, radiopaquematerial.
 5. The device of claim 4, wherein the material is anelectroformed metal.
 6. The device of claim 1, wherein said shellcomprises a material selected from the group consisting of plastic,rubber, metal, a biodegradable material, and combinations thereof. 7.The device of claim 1, further comprising at least two additional lobesin the stem forming bellows for delivery flexibility.
 8. The device ofclaim 1, further comprising an electroplated porous layer deposited onan outer surface of the shell.
 9. The device of claim 1, wherein theshell comprises an inner surface that may be activated to bond to itselfupon vacuum collapse and balloon contouring of the shell.
 10. The deviceof claim 1, wherein the shell comprises small pores in the range of 5 to25 microns in diameter.
 11. The device of claim 10, wherein the poresare filled with a dissolvable or biodegradable material.
 12. The deviceof claim 1, wherein the shell comprises large pores in the range of 25to 100 microns in diameter.
 13. The device of claim 12, wherein thepores are filled with a dissolvable or biodegradable material.
 14. Anendovascular delivery system comprising a delivery tube thatcommunicates pressure between an external device and an exclusion deviceshell and pushes the shell in a compacted shape through a body lumen.15. The endovascular delivery system of claim 14, further comprising aguidewire over which the shell is compacted and over which the compactedshell slides.
 16. The endovascular delivery system of claim 14, furthercomprising a catheter tube through which the compacted shell isdelivered from outside a body to an endovascular deployment site, andmeans to disconnect the shell from the delivery tube.
 17. Theendovascular delivery system of claim 16, wherein the disconnectionmeans comprises a pushed wire inside the delivery tube, the pushed wirehaving a distal tip adapted to shear the device from the distal tip ofthe delivery tube.
 18. The endovascular delivery system of claim 16,wherein the disconnection means comprises a second tube outside thedelivery tube, wherein the second tube has sufficient longitudinalcompressive strength to work in conjunction with the delivery tubewhereby the second tube is positioned against a proximal surface of thecollapsed shell and held in place while the delivery tube is pulledproximately to shear a stem on the shell or a proximal portion of theshell from the shell.
 19. The endovascular delivery system of claim 14,further comprising a cylindrical sheath that restrains at least aportion of the shell from expanding until the sheath is pulledproximally to allow a second portion of the shell to be pressureexpanded, facilitating the alignment of the shell at a delivery sitewithin a body.
 20. A device for intraluminal use to limit circulation orflow of fluid or other matter through a body orifice or into ananeurysmal sac from the circulatory system, the device comprising: ashell attached to a stem adapted for air tight connection to a deliverytube wherein the device transitions from a manufactured geometry to acompacted delivery geometry to an expanded geometry at the deploymentsite, to a final collapsed geometry, and, wherein the expansion resultsfrom internal positive pressure transmitted through a delivery tubecommunicating between the stem of the device and an external pump, and,wherein the collapse results from the application of internal negativepressure developed by the pump.
 21. A method of delivering anendovascular exclusion device comprising: attaching an intravasculardevice to a delivery tube; compacting the device to a smaller deliverydiameter; advancing the delivery tube to a treatment site within anartery; applying positive pressure via the delivery tube to expand theintravascular device with a waist used to locate an intravasculardevice; applying negative pressure via the delivery tube to collapse thedevice; disconnecting the device from the delivery tube; and, contouringthe device to the artery wall to fully open lumen of the artery.
 22. Aprocess for manufacturing an intraluminal device comprising: fabricatinga sacrificial mandrel with a surface that will become the inside surfaceof the device; attaching an electrical stem extension to the stern ofthe device; electroforming a thin metal shell adapted to be a pressurevessel on the mandrel; cutting the stem extension to expose mandrelmaterial; and, chemically dissolving the mandrel.